AstigmatismNCT01680354
Surgical Correction of Astigmatism
A study testing ReLEx and LASIK in people with Astigmatism, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years. During the last 2 years, a new method for correction of refractive errors has emerged. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- ReLEx and LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Myopic astigmatism between -2.0 and -5.0 diopters
- Maximal difference in spherical equivalent refraction of 2 D between eyes
- No ocular or systemic disease
- Not pregnant or breastfeeding
- Minimum BSCVA of 0.8 (decimal)
- Normal corneal topography
- Sufficient corneal thickness to allow the treatment
Who cannot join
- Subjects not fulfilling the above criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Aarhus University Hospital
Aarhus, DK-8000
About this study
Official title: Comparative Study of Surgical Laser Correction of Astigmatism
Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.
During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.
In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.
- Conditions
- Astigmatism
- Being tested
- ReLEx, LASIK
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReLExProcedure or surgery
Also called Device: Carl Zeiss Meditec Visumax Femtosecond Laser
LASIKProcedure or surgery
Also called Device: Carl Zeiss Meditec MEL-80 excimer laser
| Study group | Role | What they receive |
|---|---|---|
| ReLEx | Active comparator | One eye is treated with ReLEx the other with LASIK Receives: Procedure: ReLEx |
| LASIK | Active comparator | One eye is treated with ReLEx the other with LASIK Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 1 year
Secondary outcomes (1)
Refraction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012 (estimated)
- Study completionSep 2012
Why it stopped: Institution changed surgical method to small incision lenticule extraction. Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ivarsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680354
- Sponsor's protocol ID
- AUH_ASTIGMATISM
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2012
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Surgical Laser Correction of Astigmatism
- ClinicalTrials.gov ID
- NCT01680354
- Acronym / sponsor ID
- AUH_ASTIGMATISM
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institution changed surgical method to small incision lenticule extraction. Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.
During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.
In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReLEx | Active comparator | Procedure: ReLExOne eye is treated with ReLEx the other with LASIK |
| LASIK | Active comparator | Procedure: LASIKOne eye is treated with ReLEx the other with LASIK |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Myopic astigmatism between -2.0 and -5.0 diopters
- Maximal difference in spherical equivalent refraction of 2 D between eyes
- No ocular or systemic disease
- Not pregnant or breastfeeding
- Minimum BSCVA of 0.8 (decimal)
Key exclusion criteria (1 listed)
- Subjects not fulfilling the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReLExAlso: Device: Carl Zeiss Meditec Visumax Femtosecond Laser | Procedure or surgery | ReLEx |
| LASIKAlso: Device: Carl Zeiss Meditec MEL-80 excimer laser | Procedure or surgery | LASIK |
Primary outcome
Visual acuity
Time frame: 1 year
1 secondary outcome
Refraction
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReLEx and LASIK in people with Astigmatism, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.